Actively Recruiting
Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
Led by Ciusss de L'Est de l'Île de Montréal · Updated on 2026-05-14
25
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
C
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor
M
Maisonneuve-Rosemont Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms. The primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively. Participants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg/m2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg/m2) on postoperative days 1 and 2.
CONDITIONS
Official Title
Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient's age 18 years or older, both genders
- Good general health with an ECOG score of 0 or 1
- Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, synchronous (< 12 months) or metachronous (> 12 months)
- Complete staging with CT scan of chest, abdomen and pelvis, PET scan if appropriate, and diagnostic laparoscopy with peritoneal carcinomatosis index and biopsy
- Recommended for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC by a multidisciplinary tumor board
- Surgery planned within 4-6 weeks after neoadjuvant therapy or enrollment if no neoadjuvant therapy
- Signed and dated informed consent
- Willingness to comply with study procedures and availability for study duration
- Absolute neutrophil count (ANC) ≥ 1,500/µL; platelets > 75,000/µL
- Adequate renal function with creatinine < 1.5 times upper limit of normal or creatinine clearance ≥ 50 ml/min
- Adequate hepatic function with bilirubin less than 1.5 mg/dL (or less than 3.0 mg/dL for Gilbert's Syndrome)
You will not qualify if you...
- Other malignancies aside from appendicular and colorectal neoplasms with peritoneal involvement
- Inability to complete cytoreductive surgery or ECOG score 2 or higher
- Known allergic reaction or major toxicity to fluorouracil
- Contraindications to fluorouracil, such as coronary spasm or dihydropyrimidine dehydrogenase deficiency
- Pregnancy
- Extensive intraperitoneal adhesions preventing intraperitoneal therapy as determined by surgeon
- Any condition preventing delivery of intraperitoneal therapy
- Post-surgery conditions such as uncorrected coagulopathy, thrombocytopenia, neutropenia, active infection, or hemodynamic/respiratory compromise
- Medical unsuitability for mEPIC protocol as judged by surgical team
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
Research Team
M
Mikael Soucisse, MD, FRCSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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